(Taiwan) TWi Biotechnology successfully completes patient recruitment for Phase IIb trial of AC-201 for the treatment of Type II Diabetes

19 September, 2011 Taiwan-headquartered TWi Biotechnology, Inc. announced last week the successful patient recruitment for a multinational, multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb clinical trial of its drug candidate AC-201 for the treatment of Type II Diabetes. A combined 240 patients from 13 US sites plus 8 Taiwan sites have been enrolled in the trial, according to the announcement. With six-month treatment and one-month follow-up, completion of the trial data analysis is expected in the early second quarter of 2012. The trial's primary endpoint is defined as the change in glycated hemoglobin A1c (HbA1c) from baseline compared to placebo after twenty-four weeks of treatment. according to the company. In addition, the study is reportedly designed to demonstrate additional benefits by monitoring various secondary endpoints including change in lipid profile, change in body weight, change in blood pressure and change in beta-cell function. Meanwhile, by measuring various biomarkers such as interleukin-1Beta, interleukin-1 receptor antagonist, interleukin-6, tumor necrosis factor-Alpha, high-sensitivity C-reactive protein, plasminogen activator inhibitor-1, transforming growth factor-Beta, and adiponectin, different patient groups have been stratified in terms of clinical response, so as to develop personalized, preventive or therapeutic strategies, according to the company. "Through careful planning and execution, we are pleased with the efficient manner in which the twenty-one clinical sites, thirteen in US and eight in Taiwan, have enrolled 240 patients in the phase IIb study within 5 months since its inception, which is 4-month ahead of the expected schedule," reported Dr. M. Sherry Ku, President and CSO of TWi Biotech. "During the previous Phase IIa study, those patients with inadequate blood glucose control by multiple drug combinations of currently available oral anti-diabetic drugs were treated with AC-201 as an add-on therapy. The Phase IIa proof-of-concept study showed a mean reduction of 0.63 percent for HbA1c (N=56, p<0.05) at the end of 24 weeks treatment period, which is very promising and encouraging," said Ku, adding that she believed AC-201 would be the first-in-class oral small molecule IL-1Beta inhibitor for treating Type II Diabetes to reach the market. The company also announced that it plans to collaborate with a global partner in developing AC-201 as an add-on therapy for the treatment of Type II Diabetes and explore additional benefits of AC-201 in helping diabetic patients such as protection of kidney function and prevent further cardiovascular events that are major complications for diabetic patients. TWi Biotechnology is building its product pipeline through in-licensing of late pre-clinical stage drug candidates from renowned pharmaceutical companies and research/academic institutions. The company has three active therapeutic candidates to treat Type II Diabetes complications, retinopathy cancer and dermatology diseases.